Reported Sep 3, 2025 · Ongoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER…
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290
Is this the product you have?
- AMERICAN CONTRACT SYSTEMS, Medical
- Procedure kits and trays labeled as
1) ANTERIOR HIP PACKMODEL/ITEM NUMBER AMAH40N2)TOTAL KNEE DAN MYERMODEL/ITEM NUMBER CCKM67F3)HIP PROTHESIS PACKMODEL/ITEM NUMBER HSTH03N4)DTC ANTERIOR HIP PACK (PS 209459)MODEL/ITEM NUMBER MIAH65B5)DR WHIDD0N TOTAL HIP CPPMODEL/ITEM NUMBER MPWH01B6)KNEE ARTHROSCOPYMODEL/ITEM NUMBER SPKA57T7)ANTERIOR HIP PACKMODEL/ITEM NUMBER WVAH40H
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published CCKM67F00191072233578Lot Numbers: 42-7886011, 42-7990911; 2)MODEL/ : UDI/DI 00191072233578, Kit HSTH03N00191072189615Lot Numbers: 70-053862, 70-053457, 70-053042, 70-052715, 70-052358, 70-051850, 70-051243; 3)MODEL/ : UDI/DI 00191072189615, Kit MIAH65B00191072235411Lot Numbers: 42-7115711; 4)MODEL/ : UDI/DI 00191072235411, Kit MPWH01B00191072233271Lot Numbers: 42-8134311; 5)MODEL/ : UDI/DI 00191072233271, Kit SPKA57T00191072235848Lot Numbers: 5436801; 6)MODEL/ : UDI/DI 00191072235848, Kit WVAH40H00191072233004Lot Numbers: 12-7400011, 12-7381311, 12-7358211, 12-7082111, 12-7157111, 12-7309911; 7)MODEL/ : UDI/DI 00191072233004, Kit — Lot Numbers: 42-7897411, 42-7966211. - Amount recalled
- 588 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
This product could cause temporary or reversible health problems — stop using it.
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